MEDICAL WRITING
Medical writing services involve the preparation of scientific, regulatory, and educational documents related to drugs, biologics, medical devices, and healthcare products. It combines scientific knowledge with regulatory insight and editorial excellence to deliver high-quality documentation across the product lifecycle.
Editorial and Quality Review Services
Literature Reviews and Reference Management
Scientific Accuracy & Consistency Checks
Compliance Review (GVP, ICH, GCP, FDA, EMA guidelines)
Formatting and Publishing Support
Promotional and Market Access Writing
Value Dossiers (e.g., AMCP, GVDs).
Health Technology Assessment (HTA) Submissions.
Product Monographs and Prescribing Information (SmPC, USPI).
Marketing Claims Substantiation and Compliance Review.
Clinical and Regulatory Medical Writing
Clinical Trial Documentation
Study Protocols and Amendments: Authoring of ICH-compliant protocols, incorporating objectives, design, methodology, statistical considerations, and ethical requirements.
Investigator Brochures (IBs): Compilation of clinical and nonclinical safety and efficacy data for investigators and regulatory bodies.
Informed Consent Forms (ICFs): Preparation of patient-friendly, ethical, and compliant consent documents.
Clinical Study Reports (CSRs): ICH E3-compliant reports summarizing study methods and outcomes.
Patient Narratives: Creation of patient-level narratives for serious adverse events (SAEs), ensuring consistency and accuracy.
Regulatory Submission Documents
Common Technical Document (CTD) Modules: Writing for CTD Modules 2.5 (Clinical Overview), 2.7 (Clinical Summary), and other components for INDs, NDAs, BLAs, and MAAs.
Briefing Documents: Preparation for scientific advice meetings, pre-submission meetings, and advisory committee hearings.
PIP/PSP Documentation: Pediatric Investigation Plans (EMA) and Pediatric Study Plans (FDA).
Orphan Drug Applications, Fast Track, Breakthrough Designation Requests.
Pharmacovigilance Medical Writing
Aggregate Safety Reports
Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs): Comprehensive safety evaluations in line with ICH E2C(R2).
Development Safety Update Reports (DSURs): Periodic reports for ongoing clinical trials (ICH E2F).
PADERs: FDA-compliant Periodic Adverse Drug Experience Reports.
AddCOs (Additional Clinical Overviews): Tailored safety updates or summaries required by specific health authorities.
Risk Management Documents
Risk Management Plans (RMPs): EU RMP writing, including product overview, safety concerns, pharmacovigilance and risk minimization activities, and effectiveness evaluation.
REMS (Risk Evaluation and Mitigation Strategy): U.S. risk minimization programs.
Safety Summary Documents for Labeling and Signal Assessments.
Scientific & Educational Writing
Publications and Scientific Communication
Manuscripts for Peer-Reviewed Journals.
Abstracts, Posters, and Slide Decks for scientific conferences.
Case Reports and Review Articles.
Medical Communications Plans.
Patient and HCP Materials
Patient Education Leaflets (PILs).
Healthcare Professional (HCP) Brochures.
Instruction Manuals and FAQs.
Safety Communication Letters / Dear Healthcare Professional (DHCP) Letters.